This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.

Why Should You Attend:

FDA inspections and enforcement recently have become much more aggressive. E.g., the number of 483s and warning letters has doubled over the last five years and shipment holds and multiple product recalls have been announced even for global players. One company had to pay 500 M$ fine as a result of failed inspections and inspectors ask for details they never did before. For the near future FDA expects multifold increase of inspections through the Generic Drug User Fee Amendments (GDFUFA) that will enable FDA to substantially increase the inspection frequency to every 2 years from currently 6-7 years. In addition, the FDA has just released a new powerful guidance listing a variety of circumstances that can even delay, deny, limit or refuse an FDA inspection overall.

This webinar will help survive the new practices through getting up-to-date expert information on the new inspection practices and for preparing your organization accordingly.

Areas Covered in the Webinar:

Inspection process for API, drug and device manufacturers

Recent changes: summary and details

Going through "Reasons for Delaying or Refusing a Drug Inspection" from the new FDA guide

10 examples of recent observations/deviations that came as a surprise

Strategy to respond to the new type of inspections

Case study: Going through a typical inspection process

Preparing your staff for the new FDA inspections

Conducting FDA inspection-like internal audits

Tips on how to respond during inspections to avoid inspectional observations

The role of the exit meeting to avoid enforcement

Developing a corrective action plan with identification of the root cause

Developing a detailed preventive action plan to avoid reoccurrence

How to use all this information for all national and international inspection

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems." He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and validation around the world. This includes seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PIC/S and several other national health care agencies.

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review